This milestone stems from the companies' collaboration to expand access to affordable insulin to one million people living with diabetes in low- to middle-income countries annually by 2030
INDIANAPOLIS and CAIRO, Dec. 17, 2024 /PRNewswire/ -- The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.
This marks the first regulatory approval of EVA Pharma's insulin drug products, following Lilly and EVA Pharma's collaboration announcement in December 2022. Under this agreement, Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges.
Less than two years after the initial announcement, EVA Pharma has completed a new biologics manufacturing facility, finalized insulin formulations and stability testing processes, engaged with the local regulatory authorities to obtain approval of the insulin glargine injection, and released the first batch of the locally manufactured insulin drug product.
Additionally, EVA Pharma's human insulin injection was also submitted for local regulatory approval. Lilly and EVA Pharma continue working with the World Health Organization (WHO) to secure WHO pre-qualification for the locally manufactured human insulin injection. The WHO pre-qualification will further ensure that medicines manufactured by EVA Pharma meet the high-quality standards set by WHO.
"For more than a century, Lilly has been at the forefront of diabetes care, offering innovative solutions that make life better for people around the world," said Ilya Yuffa, executive vice president and president of Lilly International. "Our collaboration with EVA Pharma furthers our commitment to providing sustainable and accessible medicines worldwide. We will continue to work with global health systems and industry stakeholders to address systemic barriers to healthcare and expand equitable, affordable access to our medicines to transform more people's lives."
"Localizing essential medicines is the key to driving equitable access to healthcare," said Riad Armanious, CEO of EVA Pharma. "It takes bold collaboration, cutting-edge innovation, and tech-driven manufacturing to turn this vision into reality. Our collaboration with Lilly shows what's possible when we push boundaries together. This is just the beginning—we're on track to impact over a million lives annually across 56 countries, making a real difference for people living with diabetes."
This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030.
Most recently, Lilly and EVA Pharma expanded their collaboration, announcing that Lilly will license certain baricitinib manufacturing know-how to enable EVA Pharma to manufacture and supply treatment for various immunological diseases across 56 low- to middle-income countries in Africa.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. I-LLY
About EVA Pharma
EVA Pharma is dedicated to improving access to affordable, high-quality medicines around the world, focusing on three core pillars: innovation, development and sustainable access. The company leverages cutting-edge technology at two research centers bringing first-of-its-kind capabilities to the Middle East and Africa including mRNA research and development from AI prediction to biological products.
With a 5,000-strong team of professionals, EVA Pharma produces more than one million healthcare products a day at four state-of-the-art manufacturing facilities, which are internationally recognized for innovation, and have been approved by multiple regulatory agencies.
Guided by a relentless drive to ensure sustainable access to pressing yet unmet disease areas, the company's product portfolio focuses on twelve therapeutic areas: Anti-infectives, metabolic health, bone, neuroscience, oncology, respiratory, gynecology, urology and andrology, pediatrics, ophthalmology, gastrointestinal tract, family medicine to meet both local and international demand.
EVA Pharma is one of the fastest-growing healthcare companies in the Middle East and Africa, with an extensive pan-African presence, while operating in more than 70 countries worldwide. For more information, please visit: & or follow us on Facebook, LinkedIn & Instagram.
SOURCE Eli Lilly and Company
这一里程碑源于公司之间的合作,旨在到2030年每年为一百万名生活在中低收入国家的糖尿病患者提供可负担的胰岛素。
印第安纳波利斯和开罗,2024年12月17日 /PRNewswire/ -- 埃及药品管理局已批准EVA Pharma与礼来公司(纽交所代码:LLY)合作生产的胰岛素格拉齐注射液。该合作于2022年启动,旨在向至少一百万生活在低收入和中等收入国家(大部分在非洲)的1型和2型糖尿病患者提供高质量、负担得起的胰岛素的可持续供应。
这是EVA Pharma胰岛素药品首次获得监管批准,此前礼来与EVA Pharma的合作公告于2022年12月发布。在此协议下,礼来以显著降低的价格向EVA Pharma提供其原料药(API)以制作胰岛素,并提供免费的技术转让,以使EVA Pharma能够配制、灌装和完成胰岛素小瓶和卡式瓶的生产。
在初步公告后不到两年,EVA Pharma已完成新的生物制品制造设施,最终确定胰岛素配方和稳定性测试流程,与当地监管机构接洽以获得胰岛素格拉齐注射液的批准,并发布了首批当地生产的胰岛素药品。
此外,EVA Pharma的人用胰岛素注射液也已提交当地监管批准。礼来和EVA Pharma继续与世界卫生组织(WHO)合作,以确保当地生产的人用胰岛素注射液获得WHO的预认证。WHO预认证将进一步确保EVA Pharma生产的药品符合WHO设定的高质量标准。
"一个多世纪以来,礼来在糖尿病护理领域处于前沿,为全球人民提供创新解决方案,让生活更美好,"礼来国际公司执行副总裁兼总裁伊利亚·尤法说。"我们与EVA Pharma的合作加强了我们提供可持续和可接触药品的承诺。我们将继续与全球卫生系统和行业利益相关者合作,解决医疗保健中的系统性障碍,扩大大众对我们药品的公平、负担得起的获取,以改变更多人的生活。"
“本地化基本药物是推动公平医疗获取的关键,”EVA药品的首席执行官Riad Armanious表示。“这需要大胆的合作、尖端的创新和技术驱动的制造,将这一愿景变为现实。我们与莱莉的合作展示了当我们共同突破界限时,有可能实现的目标。这仅仅是开始——我们正致力于每年在56个国家影响超过一百万人,为那些生活在糖尿病中的人们带来真正的改变。”
这项合作是莱莉30x30计划的一部分,旨在到2030年每年改善3000万人在资源有限地区的优质医疗服务获取。
最近,莱莉和EVA药品扩展了合作,宣布莱莉将授权某些巴瑞替尼的制造技术,以使EVA药品能够在56个中低收入国家制造和供应各种免疫系统疾病的治疗。
关于礼来
莱莉是一家将科学转化为治疗的药品公司,旨在改善全球人们的生活。我们已经在改变生活的发现方面开创了近150年的先锋历程,如今我们的药品帮助全球数千万的人。利用生物技术、化学和基因医学的力量,我们的科学家们正在紧急推进新发现,以解决一些全球最重要的健康挑战:重新定义糖尿病护理;治疗肥胖及其最具破坏性的长期影响;推进对阿尔茨海默病的斗争;为一些最具削弱性的免疫系统疾病提供解决方案;以及将最难治疗的癌症转变为可管理的疾病。朝着更健康的世界迈出的每一步,我们的动力只有一个:让更多的人的生活变得更好。这包括开展反映我们世界多样性的创新临床试验,并努力确保我们的药物可及且负担得起。如欲了解更多信息,请访问Lilly.com和Lilly.com/news,或在Facebook、Instagram和LinkedIn上关注我们。I-LLY
关于EVA制药
EVA制药致力于改善全球人们获得负担得起的高质量药物的机会,专注于三个核心支柱:创新、开发和可持续获取。该公司在两个研究中心利用前沿科技,为中东和非洲带来首创的能力,包括从人工智能预测到生物产品的mRNA研究和开发。
EVA制药拥有5000多名专业团队,每天在四个先进的制造设施中生产超过一百万种医疗产品,这些设施因其创新而享有国际声誉,并获得多个监管机构的批准。
在不断推动可持续获取迫切而未满足的疾病领域的指导下,公司产品组合关注十二个治疗领域:抗感染、代谢健康、骨骼、神经科学、肿瘤学、呼吸、妇科、泌尿科和男科、儿科、眼科医疗、胃肠道、家庭医学,以满足本地和国际需求。
EVA Pharma 是中东和非洲增长最快的医疗保健公司之一,拥有广泛的泛非洲业务,同时在全球70多个国家开展业务。欲了解更多信息,请访问: & 或关注我们的Facebook、LinkedIn 和Instagram。
来源 礼来公司